The remedē® System for the Treatment of Central Sleep Apnea in Daily Practice

Browse trials for

• Apnea 1,423
• Sleep Apnea Syndromes 2,162
• Sleep Apnea, Central 82

Apnea

1,423 studies on the registry are indexed under Apnea; 160 are open to participants now.

This study's enrollment of 31 is below the median of 106 across 386 observational studies indexed under Apnea.

Lead sponsor

LivaNova is the lead sponsor of 39 studies on the registry; 2 are open to participants now.

Study population

Eligibility criteria

Groups and cohorts

• CSA patients without remedē system

  For all patients diagnosed with CSA who will not move forward with remedē® system therapy, the intention is to obtain information on their alternate therapy, if any, and safety information, including all cause mortality and all cause hospitalizations during phone calls at 6, 12 and 24 months after enrollment.

• CSA patients with remedē system

  For all patients diagnosed with CSA and referred for implant / or have already been implanted with remedē system, information from the implant procedure will be collected. Patients will be asked to complete quality of life questionnaires at baseline and during follow-up visits. Patients will be evaluated at the time of therapy activation which may be followed by one or more titration visits. Patient follow-ups will be programmed at 6 and 12 months, and yearly, up to 5 years post-implant, until the last patients reach their 2-year follow-up. Echocardiogram for patients with reduced ejection fraction (≤ 45%) and follow-up respiratory polygraphy are considered standard of care, however, to ensure sufficient data, related to the study objectives, are being collected, baseline and 12-months echocardiogram for a subgroup of patients and respiratory polygraphy at 12-month follow-up for all patients must be done when participating in this study:

Primary outcomes

1. Incidence of All Cause Mortality, SAEs, Stimulation Complaints, Device and/or Cardiovascular Related Events From Implant up to 5 Years.

   Collect short and long term clinical data on safety of the remede system implanted in daily practice. This outcome measure was intended to be collected up to 5 years, but at time of early study termination the data were only monitored until 24 months for 1 patient.

   Time frame: From implant up to 5 years (collected until 24 month FU)

Secondary outcomes

1. Change in Apnea-hypopnea Index as Assessed by Polygraphy Compared to Baseline

   Evaluate changes in sleep study results at 12 months compared to baseline

   Time frame: 12 months post-implant

2. Impact on Quality of Life Compared to Baseline

   Evaluate impact on Quality of Life by using a general questionnaire, a sleep-specific questionnaire and a questionnaire specific for heart failure patients

   Time frame: Up to 5 years post-implant

3. Change in Reverse Remodelling Response as Assessed by Echo Compared to Baseline

   Evaluate reverse remodeling response in patients with reduced ejection fraction at baseline

   Time frame: 12 months post implant

4. Incidence of All Cause Mortality and Hospitalizations up to 2 Years After Diagnosis of Central Sleep Apnea

   Collect site reported safety data on all patients diagnosed with central sleep apnea and not treated with the remede system

   Time frame: Up to 2 years (collected until 6M FU)

Other outcomes

1. Collect Clinical Characteristics and Symptoms of Patients With Central Sleep Apnea

   Characterstics and symptoms of patients screened for sleep disordered breathing were not collected and analyzed.

   Time frame: screening

Baseline characteristics